Freeflex
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Potassium Chloride 0.3%, Sodium Chloride 0.9% IV Infusion BP, as Steriflex No. 15 or freeflex
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Steriflex No. 15 has the following composition:
Name Specification Reference %w/v
Potassium Chloride EP 0.3
Sodium Chloride for Injections EP 0.9
3 PHARMACEUTICAL FORM
Intravenous fluid
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Potassium replacement therapy.
4.2 Posology and method of administration
Adults and Children
The volume and rate of infusion will depend upon the requirements of the individual patient and the judgement of the physician.
The rate of infusion should not exceed 10-20 mmols of potassium per hour. The total daily dosage of potassium should not exceed 200 mmols of potassium.
Children
The volume and rate of infusion will depend upon the requirements of the individual patient and the judgement of the physician.
Correspondingly reduced volumes and rates of infusion may be required.
Elderly
The volume and rate of infusion may be necessary to avoid circulatory overload, particularly in patients with cardiac or renal insufficiency.
For intravenous infusion.
4.3 Contraindications
Addison’s disease, adrenal insufficiency, acute or chronic renal disease, oliguria, anuria and patients with hyperkalaemia. The intravenous infusion of glucose solutions may also be hazardous in patients with impaired hepatic function.
4.4 Special warnings and precautions for use
Caution should be exercised in the volume and rate of infusion since fluid overload and hyperkalaemia may compromise cardiac function. Before administering potassium by the intravenous route a non-potassium containing hydrating solution should be administered to ensure adequate renal function.
The label states: Do not use unless solution is clear and free from particles.
Rapid infusion may be harmful.
Contains 10 mmol Potassium (500 ml)
Contains 20 mmol Potassium (1000 ml)
4.5 Interaction with other medicinal products and other forms of interaction
Care should be exercised in the concurrent administration of potassium containing intravenous solutions and potassium sparing diuretics.
4.6 Pregnancy and lactation
The safety of this product during pregnancy and lactation has not been established, but its use during these periods is not considered to constitute a hazard.
4.7 Effects on ability to drive and use machines
Not applicable.
4.8 Undesirable effects
Adverse effects are usually due to hyperkalaemia and include listlessness, mental confusion, parasthesiae, weakness, hypertension, arrhythmias and sometimes cardiac arrest. Thrombosis of the selected vein may occasionally occur.
4.9 Overdose
Symptoms of overdosage include hypertension, cardiac arrhythmias, heart block and cardiac arrest. Treatment is to stop infusion immediately and if there is persistent acidosis, administer an intravenous infusion of sodium bicarbonate. Hyperkalaemia may be reversed by the administration of calcium gluconate injection 10% with ECG monitoring.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Potassium chloride and sodium chloride provides essential ions to maintain the intracellular/extracellular milieu.
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
None stated.
6.1 List of excipients
Water for Injections in bulk Hydrochloric Acid Sodium Hydroxide
6.2 Incompatibilities
Incompatibilities have been demonstrated in potassium containing intravenous infusions with for example; amikacin, amphotericin, benzyl-penicillin and dobutamine.
Because of the nature of the plastic material of the steriflex bag (PVC), this solution should not be used as a vehicle for the administration of drugs which may be sorbed to the surface of the bag to varying and significant degrees.
6.3 Shelf life
500 & 1000 ml PVC Bags : 24 months.
500 & 1000 ml Polyolefin Bags : 36 months
6.4 Special precautions for storage
Store at 2° to 25 °C
6.5 Nature and contents of container
The container is a flexible 500 or 1000 ml bag made of medical grade PVC.
a) A hermetically sealed polythene bag
b) A rectangular pouch consisting of polyamide/polythene composite
c) Polyamide/Polyethylene-Propylene composite laminate welded to polypropylene
Ethylene propylene composite, plugged with a polycarbonate plug with either a bromobutyl (West 4481/45) or gum (West 7006/45) stopper.
Or a flexible 500 or 1000 ml polyolefin bag sealed in a polyolefin overwrap.
6.6 Special precautions for disposal
Opening the overwrap:
Locate the corner tabs at the end of the bag. Grip the two tabs and pull the two halves of the overwrap apart, releasing the bag onto a clean surface.
Setting up the solution:
Position the roller clamp of the giving-set to just below the drip chamber and close. Hold the base of the giving set port firmly and grip the wings of the twist of tab. Twist to remove the protective cover.
Still holding the base of the giving-set port push the set spike fully into the port to ensure a leak proof connection.
Prime the set in accordance with the manufacturer’s instructions.
7 MARKETING AUTHORISATION HOLDER
Fresenius Kabi Limited
Cestrian Court
Eastgate Way
Manor Park
Runcorn
Cheshire
WA7 1NT
MARKETING AUTHORISATION NUMBER(S)
PL 08828/0079
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
05th June 1989 / 10th November 1994
DATE OF REVISION OF THE TEXT
June 2000
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